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David Doleski

Sanofi

Compliance Head for Biologics Quality Operations

Mr. Doleski is the Compliance Head, Biologics Quality Operations for Sanofi. He is responsible for ensuring site readiness for inspections and conformance to regulatory expectations. Prior to Sanofi, Dave served in FDA for over 27 years, where he progressed through leadership positions related to FDA’s inspection and review programs for drugs and biologics in three Centers (CBER, CDER and Office of the Commissioner). His last position in FDA was Acting Deputy Director for the Office of Process and Facilities (OPF) in CDER, which is an office responsible for performing pre-approval inspections and application reviews. While at FDA, Dave was part of the leadership team that established the Office of Pharmaceutical Quality (OPQ). He led many initiatives related to inspection programs, especially related to pre-approval inspections, within a number of Compliance Offices and Quality Offices. Dave has extensive knowledge of FDA inspection and review programs, having participated at all levels, from performing inspections and reviews to leading large groups that implemented those programs. Dave has Bachelor of Science degrees from Cornell University and University of Maryland University College in biology and computer information systems respectively, as well as graduate work in Systems Engineering at Johns Hopkins University.